MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG CMPLX XTRASOFT COIL 3.5X9; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX3509
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.Initial reporter information such as the phone and email address are not available / not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (30135887) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the stent-assisted coil embolization procedure, the 3.5mm x 9cm orbit galaxy complex xtrasoft coil (640cx3509 / 30135887) became prematurely detached inside the microcatheter (unknown brand).It was reported that the physician encountered abnormal friction during the coil advancement into the microcatheter.There was no report of patient injury or complication associated with the event.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the stent-assisted coil embolization procedure, the 3.5mm x 9cm orbit galaxy complex xtrasoft coil (640cx3509 / 30135887) became prematurely detached inside the sl-10® microcatheter (stryker).It was reported that the physician encountered abnormal friction during the coil advancement into the microcatheter.There was no report of patient injury or complication associated with the event.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The device was returned for evaluation.The investigational finding is documented below.Investigation summary: two non-sterile devices were received containted in a pouch.One device is the 3.5mm x 9cm orbit galaxy complex xtrasoft coil and the other device is the sl-10® microcatheter (stryker).Visual inspection was performed.The hub and the hypo tube were inspected; several kinks were noted on the hypo tube.The introducer was not returned.The support coil and the gripper were found outside of the introducer and they were without any appearance of damage.An x-ray was taken on the sl-10® microcatheter and the embolic coil was observed stuck inside the microcatheter.A review of manufacturing documentation associated with this lot (30135887) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Functional test was precluded because the introducer was not returned and due to the kinks on the hypo tube.The issue reported in the complaint that the coil delivery system encountered abnormal friction during the coil advancement in the microcatheter could not be confirmed through functional analysis as the device could not be functionally tested.The premature coil detachment inside the microcatheter was confirmed with the x-ray that showed the embolic coil stuck inside the microcatheter.The kinks noted on the hypo tube appeared to have been caused by applied force, though this cannot be conclusively determined.It is possible that when the reported abnormal friction was felt during the attempt to advance the coil in the microcatheter, force was inadvertently applied which resulted in the observed kinks on the hypotube.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: OG CMPLX XTRASOFT COIL 3.5X9
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8951746
• Report Number: 1226348-2019-00977
• Device Sequence Number: 2470938
• Product Code: KRD
• UDI-Device Identifier: 10886704030690
• UDI-Public: 10886704030690
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 640CX3509
• Device Lot Number: 30135887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENTERPRISE2 4MMX16MM NO TIP; SL-10® MICROCATHETER (STRYKER)